Date: 2015-12-05
Type of information: Presentation of results at a congress
phase: 1
Announcement: presentation of results at the 57th American Society of Hematology (ASH) Annual Meeting in Orlando
Company: Atara Biotherapeutics (USA - CA) Memorial Sloan Kettering Cancer Center (USA - NY)
Product: cytotoxic T lymphocytes (CTL) activated against Wilms' Tumor 1 (WT1-CTL)
Action
mechanism: cell therapy. The WT1-CTL product candidate targets cancers expressing the antigen Wilms Tumor 1, or WT1. WT1 is an intracellular protein that is overexpressed in a number of cancers, including acute myeloid leukemia, or AML, multiple myeloma, or MM, and non-small cell lung, breast, pancreatic, ovarian, and colorectal cancers. The WT1-CTL product candidate is currently being studied in two ongoing Phase 1 clinical studies to test safety and initial anti-tumor efficacy of donor derived WT1-CTL in patients with AML and multiple myeloma.
Disease: relapsed-refractory multiple myeloma
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The purpose of this study is to test the safety of specialized white cells from the donor at different doses. They are called WT1 sensitized T cells. They have been grown in the lab and are immunized against a protein. The protein is called the Wilms' tumor protein, or WT1. The multiple myeloma cells make and express this protein". The investigators want to learn whether the WT1 sensitized T cells will attach to the protein and kill the myeloma cells. The investigators want to find out what effects, good and/or bad, it has on the patient and multiple myeloma. (NCT01758328)
Latest
news: * On December 5, 2015, Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company focused on developing meaningful therapies for patients with unmet medical needs in diseases that have seen limited therapeutic innovation, announced that its collaborating investigators at Memorial Sloan Kettering Cancer Center (MSK) are reporting positive Phase 1 clinical data for Atara's WT1-CTL product candidate during the 2015 ASH Annual Meeting. The findings describe the safety and activity of primary donor-derived WT1-CTLs following allogeneic hematopoietic cell transplantation (alloHCT) for the treatment of patients with relapsed-refractory multiple myeloma, including plasma cell leukemia. * On September 24, 2015, Atara Biotherapeutics announced that its collaborating investigators at Memorial Sloan Kettering Cancer Center (MSK) presented clinical data on cytotoxic T lymphocytes (CTL) activated against Wilms' Tumor 1 (WT1-CTL) at the 15th International Myeloma Workshop in Rome, Italy. The WT1-CTL product candidate targets cancers expressing the Wilms Tumor 1, or WT1, antigen. The data is derived from the treatment of patients with relapsed-refractory Multiple Myeloma (MM), including Plasma Cell Leukemia (PCL), with WT1-CTL after allogeneic hematopoietic cell transplantation (alloHCT). Dr. Guenther Koehne, MD, and colleagues, presented the following top-line clinical data from an ongoing phase 1 study: WT1, the tumor associated antigen, was detected on malignant plasma cells in those patients tested. The subjects were treated with alloHCT followed by administration of three infusions of WT1-CTLs. By one year, of seven subjects with relapsed-refractory MM or PCL receiving an alloHCT and treated with WT1-CTLs, three achieved a complete remission (CR), one achieved a partial response (PR), two had stable disease (SD) and one had progressive disease. Adverse events reported were consistent with those typically observed in this transplant population. In June 2015, Atara Bio licensed from MSK exclusive, world-wide rights to three clinical stage, allogeneic T-cell therapies for the treatment of cancers and persistent viral infections, including WT1-CTL. The WT1-CTL product candidate is being developed as a potential third party, donor-derived, "off-the-shelf" T-cell product candidate designed to target and destroy cancer cells that overexpress WT1 protein.
Dr. Guenther Koehne, M.D. and colleagues are reporting positive clinical data from the ongoing Phase 1 trial:
7 patients with relapsed-refractory MM, including PCL were treated with alloHCT followed by WT1-CTLs.
By one year, 3 achieved a complete remission (CR), 1 achieved a partial response (PR), 2 had stable disease (SD), and 1 had progressive disease. 2 patients who developed a CR remain in remission for more than 1 year.
There were no serious adverse events reported related to treatment with WT1-CTLs.
The ASH 2015 oral presentation is titled "Wilms' Tumor 1 Protein Is Highly Expressed on Malignant Plasma Cells and Provides a Novel Target for Immunotherapeutic Approaches," .
